Early Speech and Swallowing Therapy for Head and Neck Cancer

(ESSI-SURG Trial)

Overseen By Trixie Reichardt, MHSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Oral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Not only is dysphagia an independent predictor of quality of life (QoL) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. Emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (SLPs) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. This in turn has the potential to reduce complications and minimize the length of feeding tube dependency. This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic SLP speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. We will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What data supports the idea that Early Speech and Swallowing Therapy for Head and Neck Cancer is an effective treatment?

The available research shows that early involvement of Speech-Language Pathologists (SLPs) in the treatment of head and neck cancer patients is beneficial for improving speech and swallowing functions. This early intervention helps enhance the overall quality of life for these patients. The research highlights that treatments for head and neck cancer can negatively impact speech and swallowing, but early and frequent therapy can mitigate these effects. This suggests that Early Speech and Swallowing Therapy is an effective treatment for managing these issues in head and neck cancer patients. ^{1 2 3 4 5}

What safety data exists for early speech and swallowing therapy in head and neck cancer treatment?

The provided research does not directly address safety data for early speech and swallowing therapy or its variants like ESSI-SURG. The studies focus on related topics such as dysphagia quantification, afatinib safety in a different context, and factors affecting speech and swallowing outcomes post-treatment. None of the studies mention safety data for the specific therapy in question. ^{3 6 7 8 9}

Is the treatment ESSI-SURG, Standard-of-Care a promising treatment for head and neck cancer?

Yes, ESSI-SURG, Standard-of-Care is a promising treatment for head and neck cancer. Early involvement of Speech-Language Pathologists (SLPs) can improve speech and swallowing functions, which are often affected by cancer treatments. This can lead to a better quality of life for patients. Combining psychological therapy with swallowing therapy can also help reduce distress and improve overall well-being. ^{3 4 6 10 11}

Research Team

Rosemary Martino, PhD

Principal Investigator

University Health Network, Toronto

Jonathan Irish, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for newly diagnosed patients with at least T2 stage tongue cancer, scheduled for partial tongue removal and reconstruction surgery. They should be able to eat on their own after surgery and must understand English well.

Inclusion Criteria

Proficient in spoken and written English

I am newly diagnosed with stage T2 or higher tongue cancer and will have surgery and reconstruction.

Exclusion Criteria

I am scheduled for a surgery to remove my entire tongue.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Intervention

Participants engage with speech-language pathologists (SLPs) to learn swallow strategies before surgery

Baseline to surgery

Post-Surgical Treatment

Participants receive either standard care or the ESSI-SURG behavioural intervention by a live SLP

5 weeks

Regular visits with SLP

Follow-up

Participants are monitored for long-term changes in clinical and patient-reported outcomes

1 month after treatment

Treatment Details

Interventions

• ESSI-SURG
• Standard-of-Care

Trial Overview The study tests if early intervention by speech-language pathologists (SLPs) before problems start can help head and neck cancer patients recover better post-surgery. It compares this new approach (ESSI-SURG) with the usual care given.

Participant Groups

Group I: Arm 2 - Intervention Experimental Treatment 1 Intervention

Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.

Group II: Arm 1 - Control Active Control 1 Intervention

Participants in this Arm will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 81 patients with early-stage oral squamous cell carcinoma, transoral resection and sentinel node biopsy resulted in excellent long-term speech and swallowing function, with scores in the highest 10% of assessment scales after a median follow-up of 60 months.

The study found that factors like tumor size, age, and additional treatments did not significantly affect speech and swallowing outcomes, indicating that the surgical approach is effective for maintaining quality of life in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term speech and swallowing function after primary resection and sentinel node biopsy for early oral squamous cell carcinoma. Romer, CAE., Broglie Daeppen, MA., Mueller, M., et al.[2020]

In a study involving 1334 patients who underwent radical surgery for oral and oropharyngeal cancer, a significant number reported speech (63.8%) and swallowing (75.4%) impairments after treatment.

Patients with late-stage tumors (III-IV), those receiving radiotherapy, and tumors located in the floor of the mouth are at a higher risk for persistent severe speech and swallowing issues, highlighting the need for better patient education regarding these potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech and swallowing impairment after treatment for oral and oropharyngeal cancer. Suarez-Cunqueiro, MM., Schramm, A., Schoen, R., et al.[2022]

A study involving 89 head and neck cancer patients showed that using multiple patient-reported outcome instruments, specifically the Sydney Swallow Questionnaire (SSQ) and the MD Anderson Dysphagia Inventory (MDADI), provides valuable insights into swallowing function and dysphagia risk after treatment.

The analysis revealed a significant correlation between the SSQ and MDADI scores, and identified three distinct patient clusters, suggesting that a personalized approach to managing dysphagia in head and neck cancer treatment may be more effective than relying on a single assessment tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Evaluation of Head and Neck Cancer Treatment-Related Dysphagia in the Development of a Personalized Treatment Deintensification Paradigm. Quon, H., Hui, X., Cheng, Z., et al.[2018]

Early and frequent involvement of Speech-Language Pathologists (SLPs) significantly improves speech and swallowing functions in patients with head and neck cancer, enhancing their overall quality of life.

The chapter presents various strategies and tools that can help optimize communication and ensure safe swallowing for these patients, addressing the negative impacts of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the Speech-Language Pathologist (SLP) in the Head and Neck Cancer Team. Hansen, K., Chenoweth, M., Thompson, H., et al.[2019]

The Italian Speech Handicap Index is a reliable and valid tool for assessing speech impairment in head and neck cancer patients, showing strong internal consistency (Cronbach α = 0.9) and test-retest reliability.

A significant difference in scores between patients and asymptomatic subjects was found, with a cut-off value of 14.5 demonstrating high sensitivity (96%) and specificity (100%), making it effective for identifying speech-related quality of life issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Italian version of the Speech Handicap Index. Mozzanica, F., Scarponi, L., Rota, M., et al.[2021]

In the LUX-Head and Neck 1 trial involving 480 patients with recurrent/metastatic head and neck squamous cell carcinoma, afatinib showed high treatment adherence (89% of patients took ≥80% of their medication) and manageable safety across various subgroups, with common side effects including diarrhea and rash.

Afatinib demonstrated similar efficacy in progression-free survival (PFS) regardless of administration method (oral or feeding tube), with a median PFS of approximately 2.6 months, indicating it is a viable treatment option for patients with difficulties swallowing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib as second-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: Subgroup analyses of treatment adherence, safety and mode of afatinib administration in the LUX-Head and Neck 1 trial. Haddad, R., Guigay, J., Keilholz, U., et al.[2020]

In a study of 184 patients with advanced head and neck cancer who underwent chemoradiotherapy, 84.7% had normal speaking function and 63.3% had normal swallowing function on average 34.8 months after treatment, indicating a high rate of recovery.

Factors negatively impacting speech included being female, having a smoking history, and poor response to initial chemotherapy, while older age and poor performance status were linked to worse swallowing outcomes, highlighting the need for tailored patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with long-term speech and swallowing outcomes after chemoradiotherapy for locoregionally advanced head and neck cancer. Mouw, KW., Haraf, DJ., Stenson, KM., et al.[2010]

Patients with oropharyngeal head and neck cancer who were evaluated in a multidisciplinary clinic attended significantly more speech-language pathology (SLP) sessions (1.8 visits) compared to those evaluated outside this setting (0.2 visits), indicating that the clinic model enhances treatment compliance.

Older patients (≥ 60 years) and those evaluated in the multidisciplinary clinic were more likely to participate in SLP treatment, with the clinic model showing a strong association with compliance (odds ratio of 12.9), suggesting that structured, team-based care may improve adherence to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary head and neck cancer clinic and adherence with speech pathology. Starmer, H., Sanguineti, G., Marur, S., et al.[2011]

In a study of 5404 participants with head and neck cancer, significant swallowing difficulties were reported four months after treatment, with scores indicating a clinically meaningful decline, but minimal changes observed by 12 months.

Factors such as cancer type, stage, treatment method, and socio-demographic variables were identified as predictors of better swallowing outcomes, highlighting the need for targeted interventions for those at higher risk of long-term swallowing issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in, and predictors of, swallowing and social eating outcomes in head and neck cancer survivors: A longitudinal analysis of head and neck 5000. Patterson, JM., Lu, L., Watson, LJ., et al.[2022]

The study evaluated a novel intervention combining Cognitive Behavioural Therapy with swallowing therapy (CB-EST) for head and neck cancer patients with dysphagia, showing promising improvements in swallowing and quality of life measures after treatment.

Out of 43 eligible patients, 70% participated, and 25 completed the intervention, with significant improvements noted in swallowing-related quality of life and dietary restrictions, indicating the potential effectiveness of this combined approach, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of combining cognitive behavioural therapy techniques with swallowing therapy in head and neck cancer dysphagia. Patterson, JM., Fay, M., Exley, C., et al.[2022]

In a 3-month pilot clinic involving 218 patients with head and neck cancer, Speech and Language Therapists (SLTs) effectively conducted assessments and treatment planning, demonstrating a safe collaboration with otolaryngologists.

The clinic identified a low cancer diagnostic yield of 5%, but found that higher scores on voice assessments (GRBAS) and patient-reported outcomes (VHI-10) were associated with a greater risk of serious diagnoses, suggesting these measures could help in identifying patients needing further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of an Advanced Speech and Language Therapist-Led Low-Risk 2-Week Wait Clinic for Suspected Head and Neck Cancer: A UK-Based Pilot Study. Butler, J., Sellstrom, D., Eastwood, N., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term speech and swallowing function after primary resection and sentinel node biopsy for early oral squamous cell carcinoma. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Speech and swallowing impairment after treatment for oral and oropharyngeal cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Quantitative Evaluation of Head and Neck Cancer Treatment-Related Dysphagia in the Development of a Personalized Treatment Deintensification Paradigm. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Role of the Speech-Language Pathologist (SLP) in the Head and Neck Cancer Team. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Italian version of the Speech Handicap Index. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Afatinib as second-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: Subgroup analyses of treatment adherence, safety and mode of afatinib administration in the LUX-Head and Neck 1 trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Factors associated with long-term speech and swallowing outcomes after chemoradiotherapy for locoregionally advanced head and neck cancer. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

Multidisciplinary head and neck cancer clinic and adherence with speech pathology. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Trends in, and predictors of, swallowing and social eating outcomes in head and neck cancer survivors: A longitudinal analysis of head and neck 5000. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of combining cognitive behavioural therapy techniques with swallowing therapy in head and neck cancer dysphagia. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Outcomes of an Advanced Speech and Language Therapist-Led Low-Risk 2-Week Wait Clinic for Suspected Head and Neck Cancer: A UK-Based Pilot Study. [2023]